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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02119377




Registration number
NCT02119377
Ethics application status
Date submitted
16/04/2014
Date registered
21/04/2014
Date last updated
6/05/2014

Titles & IDs
Public title
First Australian National Trans Mental Health Study
Scientific title
A Mixed-Methods Study of Mental Health and Associated Factors in Transgender and Transsexual (Trans) People
Secondary ID [1] 0 0
CB:gc:6722
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Transsexualism 0 0
Condition category
Condition code

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Transgender and Transsexual People - Transgender and transsexual (trans) people aged 18 years or older living in Australia were invited to complete a questionnaire assessing a range of mental and physical health domains.
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Prevalence of depressive and anxiety disorders
Timepoint [1] 0 0
At time of entry into study (cross-sectional)
Primary outcome [2] 0 0
Perceived physical and mental health status
Timepoint [2] 0 0
At time of entry into study (cross-sectional)
Secondary outcome [1] 0 0
Use of alcohol, tobacco, and illicit drugs
Timepoint [1] 0 0
At time of entry into study (cross-sectional)
Secondary outcome [2] 0 0
Patient-doctor relationship between trans people and their general practitioners, and doctors generally
Timepoint [2] 0 0
At time of entry into study (cross-sectional)
Secondary outcome [3] 0 0
Body image
Timepoint [3] 0 0
At time of entry into study (cross-sectional)
Secondary outcome [4] 0 0
Factors that encourage and discourage trans people from accessing health care
Timepoint [4] 0 0
At time of entry into study (cross-sectional)
Secondary outcome [5] 0 0
Factors that protect and promote mental health in trans people
Timepoint [5] 0 0
At time of entry into study (cross-sectional)
Secondary outcome [6] 0 0
Use of hormone therapy and desire for, and uptake of transition-related surgery
Timepoint [6] 0 0
At time of entry into study (cross-sectional)
Secondary outcome [7] 0 0
Experiences of discrimination and harassment
Timepoint [7] 0 0
At time of entry into study (cross-sectional)
Secondary outcome [8] 0 0
Desire to, and success changing identifying documentation
Timepoint [8] 0 0
At time of entry into study (cross-sectional)

Eligibility
Key inclusion criteria
* Live in Australia
* Self-identify as trans
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
* Aged less than 18 years

Study design
Purpose
Duration
Selection
Timing
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/08/2013
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/12/2013
Sample size
Target
Accrual to date
Final
946
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 0 0
Curtin University - Perth
Recruitment postcode(s) [1] 0 0
6102 - Perth

Funding & Sponsors
Primary sponsor type
Other
Name
Curtin University
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Beyondblue (The National Depression Initiative)
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
This is an Internet-based survey of transgender and transsexual (trans) people aged 18 years and older living in Australia. This population has received limited attention from public health researchers, planners, and practitioners. However, a growing body of evidence suggests that trans people experience disparities in several important areas of health compared with the population generally. In particular, trans people are more likely to experience mental health problems (notably depression and anxiety disorders), use alcohol, tobacco, and illicit drugs, and think about or attempt suicide. Additionally, trans people commonly report that their physical and mental health needs are not met, and underutilise preventive health care.

Participants were recruited using several non-probability sampling techniques, (including purposive sampling and snowball sampling), because random sampling is not possible with this population. Medical, social, support, and advocacy networks used by trans people were used to promote the study. A mixed quantitative and qualitative methodology was used. Validated quantitative instruments were used to obtain measures of health and well-being, which will be compared against population norms. Qualitative items complement these measures, providing rich experiential data.

The investigators hypothesised that:

* the prevalence of depressive and anxiety disorders will be higher than for the population generally, and that these conditions will commonly be undiagnosed and untreated;
* depressive and anxiety disorders will be associated with risky behaviours, such as tobacco, alcohol, and illicit drug use; and,
* trans people will report poor relationships with medical practitioners.

The investigators hypothesised that poor mental health is a consequence of several interrelated factors: body dysphoria (as a consequence of experiencing difficulty accessing medical treatment to alter sexual characteristics); societal discrimination and stigma (including harassment and violence); institutionalised discrimination (including difficulty changing identifying documents, and exclusion of surgical procedures and related treatments from public and private health systems); social isolation; and the belief held by many clinicians that transsexualism is a mental disorder (which may be a barrier to trans people forming trusting relationships with medical practitioners).
Trial website
https://clinicaltrials.gov/study/NCT02119377
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Zoë Hyde, MPH PhD
Address 0 0
Curtin University
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT02119377